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510(k) K822392

MYOCUR BLADE PAC by Myocure, Inc. — Product Code HMN

K822392 is an FDA 510(k) premarket notification submitted by Myocure, Inc. for the device "MYOCUR BLADE PAC". The FDA issued a decision of Substantially Equivalent on August 25, 1982. The device falls under product code HMN (Suture, Nonabsorable, Ophthalmic), a Class III device. Myocure, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1982
Date Received
August 9, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorable, Ophthalmic
Device Class
Class III
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Myocure, Inc.

  • K880347 — ANESTHESIA/RETROBULBAR NEEDLES (May 3, 1988)
  • K880346 — CANNULAS (May 3, 1988)
  • K880345 — CYSTOTOMES/KNIFES (May 3, 1988)
  • K874057 — OPHTHALMIC TIP & BLADE SCALPELS (December 23, 1987)
  • K874056 — OPHTHALMIC DISPOSABLE BLADES (December 22, 1987)
  • K873385 — OPHTHALMIC PHACO-BLADE (September 21, 1987)
  • K864371 — SURGICAL SKIN MARKER (November 17, 1986)
  • K863662 — OPHTHALMIC SURGICAL DRAPE (October 20, 1986)
  • K863663 — OPHTHALMIC SURGICAL OCULAR MARKERS (October 20, 1986)
  • K863666 — THE SAVER KIT (October 20, 1986)

FDA data resources